FDA.reportPublic FDA data

Soft-tissue/mesh anchor, non-bioabsorbable

Definition
A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.
GUDID devices
116
Last updated
2022-11-01 08:20:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000645113Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.SA-852022-10-22
00763000645120Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.SG-642022-10-22
00763000645137Heli-FX™ EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.HG-16-62-282022-10-22
00763000645144Heli-FX™ Thoracic EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.HA-18-1142022-10-22
00763000645151Heli-FX™ Thoracic EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.HG-18-90-222022-10-22
00763000645168Heli-FX™ Thoracic EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.HG-18-90-322022-10-22
00763000645175Heli-FX™ Thoracic EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.HG-18-90-422022-10-22
00763000645182Heli-FX™ Ancillary EndoAnchor™ CassetteMEDTRONIC VASCULAR, INC.EC-052022-10-22
05708932757423SaffronColoplast A/S5203402022-09-09
05708932757430SaffronColoplast A/S5203502022-09-09
07630345797018FairFix Adjustable Button SystemMedacta International SA05.05.01322022-08-19
07630345797025FairFix Adjustable Button SystemMedacta International SA05.05.01332022-08-19
07630345797032FairFix Adjustable Button SystemMedacta International SA05.05.01342022-08-19
07630345778697FairFix Adjustable Button SystemMedacta International SA05.05.01192022-06-13
07630345778703FairFix Adjustable Button SystemMedacta International SA05.05.01222022-06-13
20884521070452TackerCovidien LPOMS-TTH2015-09-02
07630345703927FairFix Adjustable Button SystemMedacta International SA05.05.00912021-03-29
07630345703934FairFix Adjustable Button SystemMedacta International SA05.05.00922021-03-29
07290017155357TissueTak™VIA SURGICAL LTDAS-19022TT2021-03-04
07630040727754MectaLock PEEK Suture AnchorMedacta International SA05.10.0012021-02-24
07630040727761MectaLock PEEK Suture AnchorMedacta International SA05.10.0022021-02-24
07630040727778MectaLock PEEK Suture AnchorMedacta International SA05.10.0032021-02-24
07630040727785MectaLock TI Suture AnchorMedacta International SA05.10.0112021-02-24
07630040727792MectaLock TI Suture AnchorMedacta International SA05.10.0122021-02-24
07630040727808MectaLock PEEK Suture AnchorMedacta International SA05.11.0012021-02-24
07630040727815MectaLock PEEK Suture AnchorMedacta International SA05.11.0022021-02-24
07630040727822MectaLock PEEK Suture AnchorMedacta International SA05.11.0032021-02-24
07630345701442MectaLock PEEK Suture AnchorMedacta International SA05.10.0042021-02-24
07630345701459MectaLock PEEK Suture AnchorMedacta International SA05.10.0052021-02-24
07630345701466MectaLock PEEK Suture AnchorMedacta International SA05.10.0062021-02-24
07630345712738SnugFit All-Suture AnchorMedacta International SA05.11.0212021-01-21
07630345712745SnugFit All-Suture AnchorMedacta International SA05.11.0222021-01-21
07630345712752SnugFit All-Suture AnchorMedacta International SA05.11.0232021-01-21
07630345712769SnugFit All-Suture AnchorMedacta International SA05.11.0242021-01-21
07630345714060SnugFit All-Suture AnchorMedacta International SA05.11.0252021-01-21
07630345717184SnugFit All-Suture AnchorMedacta International SA05.11.0262021-01-21
08436568350141AnchorsureDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLA-SURE022020-10-19
08437007606904AnchorsureDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLA-SURE2020-10-19
10818674025697FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWirT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONAR-4570R2020-10-18
10818674025703FiberStitch™ Implant, 24° Curve with two Polyester Implants and 2-0 FiberWire® ST.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONAR-4570-242020-10-18
10818674021798FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® SutuT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONAR-45702019-10-11
00643169647565APTUS Heli-FX®MEDTRONIC VASCULAR, INC.HG-18-90-422015-10-21
00643169647572APTUS Heli-FX®MEDTRONIC, INC.SG-642015-10-21
00643169647602APTUS Heli-FX®MEDTRONIC VASCULAR, INC.HA-18-1142015-10-21
00643169647626APTUS Heli-FX®MEDTRONIC VASCULAR, INC.HG-16-62-282015-10-21
00643169647640APTUS Heli-FX®MEDTRONIC VASCULAR, INC.HG-18-90-222015-10-21
00643169647664APTUS Heli-FX®MEDTRONIC VASCULAR, INC.HG-18-90-322015-10-21
00643169647695APTUS Heli-FX®MEDTRONIC, INC.SA-852015-10-21
00763000006617Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.SA-852017-08-06
00763000006624Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.SG-642017-09-17
00763000006631Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-16-62-282017-09-17
00763000006648Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HA-18-1142017-08-06
00763000006655Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-18-90-222017-09-17
00763000006662Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-18-90-322017-09-17
00763000006679Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-18-90-422017-09-17
00763000006686Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.EC-052017-08-06
00763000025250Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.SG-642017-11-10
00763000025267Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-16-62-282017-11-10
00763000025274Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-18-90-222017-11-10
00763000025281Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-18-90-322017-11-10
00763000025298Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-18-90-422017-11-10
00763000225933Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.SA-852019-06-29
00763000225940Heli-FX™ EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.HA-18-1142019-06-29
00763000225957Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.EC-052019-09-16
00763000225964Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.SG-642019-05-10
00763000225971Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-16-62-282019-05-10
00763000225988Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-18-90-222019-06-29
00763000225995Heli-FX™ EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.HG-18-90-322019-06-29
00763000226008Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.HG-18-90-422019-06-29
10801741016711PermaFix Fixation SystemDavol Inc.01131192015-05-20
10801741016728PermaFix Fixation SystemDavol Inc.01131202015-05-20
10801741094986CapSure Permanent Fixation SystemDavol Inc.01132152015-06-22
10801741094993CapSure Permanent Fixation SystemDavol Inc.01132302015-06-22
00880304460454MAXFIREBiomet Orthopedics, LLC9003392015-10-24
00880304475915MAXFIRE MARXMENBiomet Orthopedics, LLC9003212015-10-24
00880304475922MAXFIRE MARXMENBiomet Orthopedics, LLC9003202015-10-24
00880304690066JuggerStitch®Biomet Orthopedics, LLC1100247722017-04-26
00880304690073JuggerStitch®Biomet Orthopedics, LLC1100247732017-04-26
00880304806818JUGGERSTITCH™Biomet Orthopedics, LLC1100255702017-03-16
00880304806825JUGGERSTITCH™Biomet Orthopedics, LLC1100255712017-03-16